By Brady Huggett
Corixa Corp. chose a European marketing partner for its product, Bexxar ¿ currently in a holding pattern as the FDA considers Corixa¿s latest additions to the biologics license application ¿ and also added muscle to its adjuvant license agreement with Wyeth Lederle Vaccines.
¿It was key for [Corixa] because it is not a marketing company, so they needed someone in Europe,¿ said Michael Wood, analyst for Lehman Brothers in New York. ¿It¿s partnered with GlaxoSmithKline [plc, of London] in the U.S., so now it has someone for the two largest territories for this product.¿
Amersham Health, of London, will handle Bexxar, a radioimmunotherapy, in Europe for Corixa. The agreement calls for as much as $15 million of Corixa stock to be purchased by Amersham ¿ $5 million purchased at a premium as the agreement is executed and an option for another $10 million to be sold in the future at times chosen by Corixa. Corixa, of Seattle, stands to receive multimillion-dollar milestone payments from Amersham for regulatory approval of Bexxar in Europe and also if Bexxar reaches certain sales levels. Finally, Corixa will earn undisclosed royalties on sales, royalties Corixa¿s CEO and chairman, Steven Gillis, described as ¿consistent with a product that is in a late stage of development.¿
¿We need to have a radiolabeling manufacturing facility in Europe in order to service the European market,¿ Gillis said. ¿It can¿t be serviced from our North American supplier. That capability gives [Amersham] a leg up for being a partner for us.¿
Wood said he was caught off guard by the selection, for one reason.
¿I¿m surprised that [Corixa] didn¿t chose someone with more of an established franchise in therapeutics,¿ he said. ¿Amersham is more diagnostic and imaging. Selling a therapeutic agent to these nuclear medicine physicians will be somewhat of a stretch. I think [Amersham] will hire a sales team for that.¿
Bexxar is designed to treat non-Hodgkin¿s lymphoma patients who cannot tolerate chemotherapy or do not respond to it. The FDA accepted Corixa¿s BLA filing in November, then responded to it in March, asking for more data but not additional trials. The news pulled Corixa¿s stock down more than 14 percent and forced the company to cut its staff by 10 percent to 15 percent to reduce expenditures. Corixa turned in its final response to the data request in September. (See BioWorld Today, March 20, 2001.)
The next step for Bexxar should be review by the Oncologics Drug Advisory Committee. In a San Francisco-based Pacific Growth Equities research note, analyst Thomas Dietz suggested that Bexxar might be thrown before the committee in December, although Gillis said he ¿couldn¿t speculate today on when that would be.¿
Across the ocean, however, Wood said Corixa ¿isn¿t likely to file for another three to six months,¿ adding that the product in Europe is ¿a year behind the U.S.¿ But even with the new deal, the responsibility of getting the product approved rests with Corixa: It must generate, accrue and bundle all data needed to support registration of Bexxar in Europe. Amersham will rename the product and, if approved, control both its manufacture and marketing.
Separately, Corixa released news Monday concerning an expanded license agreement with Wyeth Lederle Vaccines, a business unit of American Home Products Corp., of Madison, N.J. The companies grew their existing deal involving Corixa¿s MPL adjuvant to include a second adjuvant, Ribi-529, an aminoalkyl glucosamine 4-phosphate molecule that has shown immunostimulatory activities in animal vaccine studies.
¿The [Ribi-529] program is a joint development program with Rhein Biotech [of Dusseldorf, Germany], but this is the first major adjuvant license for 529,¿ Gillis said.
The amendment states that Wyeth Lederle has permission, although co-exclusive or nonexclusive, to use the adjuvant in vaccines to prevent or treat several diseases, including certain infectious diseases and one autoimmune disease. Wyeth continues to have the right to use the MPL adjuvant in vaccines in several disease targets.
Corixa will receive license fees, an undisclosed transfer price and minimum royalties, as well as royalties based on product sales. Ribi-529 currently is in a pivotal trial in hepatitis B patients in Argentina. The importance of the expanded deal can be seen, at least in part, Gillis said, by the additional revenue the deal should generate.
Gillis said the company expects to release third-quarter earnings figures on Wednesday. Its cash position at the end of the second quarter was about $155 million and the company had about 40 million shares outstanding, or roughly 50 million on a fully diluted basis.
The deals do more than just provide funding, though.
¿It¿s a continued testament to the breadth of our pipeline and our ability to leverage technology the company has,¿ Gillis said, ¿both for near-term product sales and powering others¿ products. And they are both important for providing cash.¿
Corixa¿s stock (NASDAQ:CRXA) slid 70 cents Monday on a down market day, closing at $12.75.